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Manufacturing Process Engineer

Job description

Job Title: Manufacturing Process Scientist/Process Engineer
Role Type: Permanent
Location: Co. Mayo

Role Overview:
Force Recruitment have partnered with a leading biologics pharmaceutical manufacturer based in Mayo to hire a Process Scientist/ Manufacturing Process Engineer on a full time basis. The role will be responsible for optimizing and improving processes within this aseptic biologics pharmaceutical manufacturing environment. This role will join a dedicated manufacturing team and it’s an exciting time to join this company while they are in a ramp up stage, and bringing new products to market.
Duties & Responsibilities:

  • Provide technical assistance to the manufacturing areas relating to the process and equipment to address issues and exceptions or support improvements. 

  • Develop and implement changes that will enhance equipment performance, product quality, reduce manufacturing costs and maximise efficiencies. 

  • Develop and modify procedures as needed to support the manufacturing areas. Submit Change plans and create investigation reports. 

  • Support the transfer of new products to the manufacturing area.

  • Participate in process, equipment and facilities validation efforts and project implementation. 

  • Maintain manufacturing area equipment in compliance with site calibration and maintenance program 

  • Provide support to Technical Shift Leads on batch records 

  • Provide assistance and present when required at Regulatory Inspections 

  • Comply with policies and procedures and regulatory agency regulations. 

  • Evaluation and implement new equipment and process technology. 

  • Initiate capital project ideas dealing with safety, quality improvements, increases in capacity and/or cost reduction. 

Qualifications & Experience Required:

  • Bachelor’s degree in Chemical, Mechanical Engineering, or a related discipline is required

  • A minimum of 2 years’ experience in process / equipment engineering in a manufacturing environment of biotechnology, pharmaceutical plant desired.

  • Lean Six Sigma/ Continuous Improvement experience is desirable 

  • Detailed knowledge of CGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.

  • Possess strong technical knowledge and application of concepts, practices, and procedures. 

  • Good interpersonal skills to develop working relationships with people at all levels.

  • Ability to lead projects.

  • Ability to quickly adopt to changing business / project demands.